The Clinical Efficacy Observation Of Zigui Xiehuo Decoction In The Treatment Of Perimenopausal Women Generalised Anxiety Disorder For Yin-deficiency And Fre-excess Type

Objective:This research aims at evaluating the clinical efficacy and safety of Zigui xiehuo decoction combined with paroxetine hydrochloride in the perimenopausal patients with generalised anxiety disorder for yin-deficiency and fre-excess type,by observing the changes of Hamilton Anxiety Scale(HAMA)scores,Kupperman Index scores,TCM syndrome scores,three types of sex hormones numerical(E2,FSH,LH)and other indicators before and after treatment.Methods:This research adopts the randomized controlled research method.The research objects were from the clinic and ward of the departments of gynaecological and neurology,Xiamen Hospital of Traditional Chinese Medicine,and the department of psychiatry,Xiamen Xianyue hospital,from January 2018 to November 2018.A total of 84 patients with generalized anxiety disorder were included,which were randomly divided into the observation group(42 cases)and the control group(42 cases).The control group was given paroxetine hydrochloride tablets 20 mg,qd,oral treatment;the observation group was given "Zigui Xiehuo Decoction" a dose/day on the basis of oral administration of the same dose of paroxetine hydrochloride tablets.The study was a course of treatment for 4 weeks and continuous observation for 12 weeks.By observing the changes of patients' HAMA scores,Kupperman Index scores,TCM syndrome scores,three types of sex hormones numerical(E2,FSH,LH)before and after treatment,taking liver and kidney function and electrocardiogram as safety indicators,the efficacy and safety of "Zigui Xiehuo Decoction" were evaluated by statistical analysis.Results:1.A total of 84 patients were enrolled in this study,among which 79 patients completed the clinical observation,including 2 patients were lost in the observation group and 3 patients were lost in the control group,and the total shedding rate was 5.95%.2.Before the treatment,there is no statistical significance in the age,course of disease,educational level,professional distribution,HAMD scores,HAMA scores,Kupperman Index scores,three types of sex hormones numerical(E2,FSH,LH),single TCM symptom distribution and TCM symptom scores between the two groups(P>0.05).The two groups were comparable.3.TCM syndrome scores:Comparing within the two groups,both groups can significantly improve anxiety and related clinical symptoms(P<0.01).Comparing the two groups in the same period,the difference was significant after 4 weeks of treatment(P<0.05),and the score of the observation group decreased more significantly after 8 weeks and 12 weeks of treatment(P<0.01).4.HAMA scores:Comparing within the two groups,the HAMA score can be significantly reduced.(P<0.01).Comparing the same period,the scores of the two groups were different after 4w and 8w treatment(P<0.05),and the score of the observation group was significantly decreased after 12 w treatment(P<0.01).5.Kupperman Index scores:Comparing within the two groups,the scores were significantly lower than those before treatment(P<0.01).Comparing the two groups in the same period,there was a difference in the score after 4w treatment(P<0.05),and the score decreased more significantly in the observation group after 8w and 12 w treatment(P<0.01).6.Three types of sex hormones:Comparison between the two groups,E2,FSH and LH sex hormone levels were significantly improved after 12 w treatment in both groups(P<0.01).After treatment for 12 weeks between the two groups,the observation group was significantly higher than the control group E2,and the LH and FSH were significantly lower(P<0.05,P<0.01).7.Overall clinical efficacy:The total effective rate of the observation group was 92.50%,and the total effective rate of the control group was 76.92%.The clinical efficacy of the two groups is statistically significant.(P<0.01).8.Security analysis:No adverse events occurred during the clinical observation,and no abnormal changes were found in the laboratory indexes such as liver and kidney function and electrocardiogram.There was no significant difference between the two groups before and after treatment(P>0.05).Conclusion:Ziqui xiehuo decoction combined with paroxetine hydrochloride is effective in the treatment of perimenopausal women generalised anxiety disorder for yin-deficiency and fre-excess type.It is more advantageous in lowering TCM symptom scores,HAMA scores,Kupperman Index scores and three types of sex hormones(E2,FSH,LH)than paroxetine hydrochloride alone.And It shows no obvious untoward effective,and actually proves to be favorably safe.